NDC 54868-4730 Ortho Tri Cyclen Lo

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
54868-4730
Proprietary Name:
Ortho Tri Cyclen Lo
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Start Marketing Date: [9]
01-23-2003
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
BLUE (C48333 - LIGHT BLUE)
BLUE (C48333 - DARK BLUE)
GREEN (C48329 - DARK GREEN)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
O;M;180
O;M;215
O;M;250
O;M;P
Score:
1

Product Packages

NDC Code 54868-4730-0

Package Description: 1 KIT in 1 BLISTER PACK

Product Details

What is NDC 54868-4730?

The NDC code 54868-4730 is assigned by the FDA to the product Ortho Tri Cyclen Lo which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-4730-0 1 kit in 1 blister pack . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Ortho Tri Cyclen Lo?

ORTHO TRI-CYCLEN® Lo Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.In an active controlled clinical trial 1,673 subjects completed 11,003 cycles of ORTHO TRI-CYCLEN® Lo use and a total of 20 pregnancies were reported in ORTHO TRI-CYCLEN® Lo users.99 This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 2.36 per 100 women-years of use.Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant® system, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.Table 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States.% of Women Experiencing an Unintended Pregnancy Within the First Year of Use% of Women Continuing Use at One Year MethodTypical Use Perfect Use (1)(2)(3)(4)Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills).Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.Source: Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.Chance 8585Spermicides 26640Periodic abstinence2563  Calendar9  Ovulation Method3  Sympto-Thermal 2  Post-Ovulation1Withdrawal194CapWith spermicidal cream or jelly.  Parous Women402642  Nulliparous Women20956Sponge  Parous Women402042  Nulliparous Women20956Diaphragm20656Condom   Female (Reality®)21556  Male14361Pill571  Progestin Only0.5  Combined0.1IUD  Progesterone T2.01.581  Copper T380A0.80.678  LNg 200.10.181Depo-Provera®0.30.370Norplant® and Norplant-2®0.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100ORTHO TRI-CYCLEN® Lo has not been studied for and is not indicated for use in emergency contraception.

Which are Ortho Tri Cyclen Lo UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Ortho Tri Cyclen Lo Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Ortho Tri Cyclen Lo?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".